Ещё один очередной успех
увидеть комментарии (0)
11.07.2018
Источник: Звезда | «Ученые создали самую эффективную вакцину против ВИЧ» | https://tvzvezda.ru/news/vstrane_i_mire/content/201807100347-2nfi.htm |
Исследования международной группы ученых увенчались успехом: созданная ими вакцина Ad26 против вируса иммунодефицита человека оказалась действительно эффективной. Результаты исследования опубликованы в журнале The Lancet.
Исследование было слепым вдвойне, так как ни испытуемые, ни организаторы не знали до конца теста, какая из групп принимает вакцину, а какая - пустышку. В исследовании приняли участие 393 здоровых добровольца 18-50 лет из 12 клиник Восточной и Южной Африки, США и Таиланда.
Отмечается, что, по результатам испытания, все схемы вакцинирования с Ad26 оказались безопасными для здоровья добровольцев. Были выявлены незначительные побочные эффекты: боль в месте инъекции, головокружения и диарея у некоторых испытуемых. Вакцинация способствовала увеличению числа антител против белков вируса, а также интенсивному фагоцитозу и активации иммунных Т-клеток.
Кроме того, ученые решили проверить вакцину на 72 макаках, у которых был такой же иммунный ответ.
По словам руководителя исследовательской группы вирусолога Дэна Баруша, по всей видимости, это не окончательная вакцина, однако она станет феноменальным прорывом в медицине. Исследователи заметили, что окончательные результаты испытания будут получены к 2021 году. Только тогда можно будет говорить о фармацевтическом выпуске вакцины.
************************
Source: MedicalXpress | «Novel HIV vaccine candidate is safe and induces immune response in healthy adults and monkeys» | https://medicalxpress.com/news/2018-07-hiv-vaccine-candidate-safe-immune.html |
<... New research published in The Lancet shows that an experimental HIV-1 vaccine regimen is well-tolerated and generated comparable and robust immune responses against HIV in healthy adults and rhesus monkeys. Moreover, the vaccine candidate protected against infection with an HIV-like virus in monkeys.
Based on the results from this phase 1/2a clinical trial that involved nearly 400 healthy adults, a phase 2b trial has been initiated in southern Africa to determine the safety and efficacy of the HIV-1 vaccine candidate in 2,600 women at risk for acquiring HIV. This is one of only five experimental HIV-1 vaccine concepts that have progressed to efficacy trials in humans in the 35 years of the global HIV/AIDS epidemic.
Previous HIV-1 vaccine candidates have typically been limited to specific regions of the world. The experimental regimens tested in this study are based on 'mosaic' vaccines that take pieces of different HIV viruses and combine them to elicit immune responses against a wide variety of HIV strains.
"These results represent an important milestone. This study demonstrates that the mosaic Ad26 prime, Ad26 plus gp140 boost HIV vaccine candidate induced robust immune responses in humans and monkeys with comparable magnitude, kinetics, phenotype, and durability and also provided 67% protection against viral challenge in monkeys", says Professor Dan Barouch, Director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center and Professor of Medicine at Harvard Medical School, Boston, USA who led the study. ...>
*************************
Source: The Lancet | «Evaluation of a mosaic HIV-1 vaccine in a multicentre, randomised, double-blind, placebo-controlled, phase 1/2a clinical trial (APPROACH) and in rhesus monkeys (NHP 13-19)» | https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)31364-3/abstract |
<... We conducted a multicentre, randomised, double-blind, placebo-controlled phase 1/2a trial (APPROACH). Participants were recruited from 12 clinics in east Africa, South Africa, Thailand, and the USA. We included healthy, HIV-1-uninfected participants (aged 1850 years) who were considered at low risk for HIV-1 infection. We randomly assigned participants to one of eight study groups, stratified by region. Participants and investigators were blinded to the treatment allocation throughout the study. We primed participants at weeks 0 and 12 with Ad26.Mos.HIV (5 × 1010 viral particles per 0=5 mL) expressing mosaic HIV-1 envelope (Env)/Gag/Pol antigens and gave boosters at weeks 24 and 48 with Ad26.Mos.HIV or modified vaccinia Ankara (MVA; 108 plaque-forming units per 0=5 mL) vectors with or without high-dose (250 μg) or low-dose (50 μg) aluminium adjuvanted clade C Env gp140 protein. Those in the control group received 0=9% saline. All study interventions were administered intramuscularly. Primary endpoints were safety and tolerability of the vaccine regimens and Env-specific binding antibody responses at week 28. Safety and immunogenicity were also assessed at week 52. All participants who received at least one vaccine dose or placebo were included in the safety analysis; immunogenicity was analysed using the per-protocol population. We also did a parallel study in rhesus monkeys (NHP 13-19) to assess the immunogenicity and protective efficacy of these vaccine regimens against a series of six repetitive, heterologous, intrarectal challenges with a rhesus peripheral blood mononuclear cell-derived challenge stock of simian-human immunodeficiency virus (SHIV-SF162P3). ...>
назад